Veru Inc. — Fiscal 2026 Third Quarter Earnings Summary

Financial Performance

• Research and development expenses for the quarter ended June 30, 2026, increased to $4.4 million from $3.0 million in the same period of fiscal 2025.
• General and administrative expenses for the quarter decreased to $3.4 million from $5.0 million in the prior year period.
• Operating loss from continuing operations for the quarter increased to $7.7 million from $7.5 million in the prior year period.
• Net loss for the quarter decreased to $7.0 million ($0.30 per share) compared to $7.3 million ($0.50 per share) in the prior year period.
• Year-to-date research and development expenses decreased to $8.8 million from $12.7 million in fiscal 2025.
• Year-to-date general and administrative expenses decreased to $11.5 million from $15.4 million in fiscal 2025.
• Year-to-date operating loss from continuing operations decreased to $20.4 million from $25.9 million in fiscal 2025.
• Year-to-date net loss decreased to $15.1 million ($0.68 per share) compared to $24.2 million ($1.65 per share) in fiscal 2025.
• Cash, cash equivalents, and restricted cash were $23.9 million as of June 30, 2026, compared to $15.8 million as of September 30, 2025.
• Net cash used in operating activities for the nine months ended June 30, 2026, was $20.6 million, compared to $24.6 million in the prior year period.
• Net cash provided by investing activities for the nine months ended June 30, 2026, was $5.3 million, compared to $18.9 million in the prior year period.
• Net cash provided by financing activities for the nine months ended June 30, 2026, was $23.3 million, compared to net cash used of $4.2 million in the prior year period.
• Total assets were $37.0 million as of June 30, 2026, compared to $29.8 million as of September 30, 2025.
• Total liabilities were $8.7 million as of June 30, 2026, compared to $11.5 million as of September 30, 2025.
• Total stockholders' equity was $28.4 million as of June 30, 2026, compared to $18.3 million as of September 30, 2025.

Guidance and Future Outlook

• Interim analysis results from the Phase 2b PLATEAU clinical trial are expected in the first quarter of calendar year 2027.
• Final topline clinical data for the Phase 2b PLATEAU trial is expected in the fourth quarter of calendar year 2027.
• The company plans to prioritize the use of current internal cash to fund the PLATEAU Phase 2b clinical trial.
• Advancement of sabizabulin will depend on securing additional funding.
• The company intends to continue seeking feedback from the FDA regarding clinical trial designs.

Business Segments and Product Lines

• The Phase 2b PLATEAU clinical trial of enobosarm and semaglutide for high-quality weight loss is fully enrolled with 239 patients, exceeding the targeted enrollment of 200.
• The Phase 2b PLATEAU study evaluates enobosarm 3mg in older patients (age ≥ 65) with obesity (BMI ≥ 35) initiating semaglutide treatment to assess total body weight, fat mass, lean mass, physical function, and bone mineral density.
• The Phase 2b QUALITY clinical study was positive, demonstrating that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16-week active weight loss period.
• The Phase 2b QUALITY maintenance extension study showed that enobosarm monotherapy prevented the regain of weight lost when semaglutide was discontinued.
• Enobosarm is being developed as an oral selective androgen receptor modulator (SARM) to make weight reduction by GLP-1 RA drugs more tissue selective.
• Sabizabulin is being developed as a microtubule disruptor for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease.

Market and Competitive Landscape

• There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density, particularly in older patients with low muscle reserves and obesity.
• The company aims to demonstrate that enobosarm can break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment.

Risks and Challenges

• The supply agreement with Novo Nordisk could be terminated prior to the completion of the PLATEAU Phase 2b clinical trial, including pursuant to a provision permitting Novo Nordisk to terminate for convenience upon 60 days' prior notice.
• Advancement of sabizabulin depends on securing additional funding.
• Clinical trial results may be unsuccessful or insufficient to meet regulatory standards.
• The FDA may disagree that clinical trial designs support approval or may require additional Phase 3 studies.
• There is a risk of delays in clinical trial timing or patient enrollment.
• The company may face competition from new or existing competitors with greater resources and capabilities.
• There is a risk that products, if approved, may not be commercially successful.

Management Commentary and Tone

• Mitchell Steiner, M.D., Chairman, President, and CEO, stated the company is "extremely pleased with the continued enobosarm progress."
• Dr. Steiner highlighted that the accomplishments mark important milestones in advancing enobosarm as a potential combination therapy with GLP-1 receptor agonists.
• Management thanked patients and investigators for their enthusiasm in expeditiously reaching full enrollment.
• The company remains on track to report interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027.

Other Key Points

• In June 2026, the company announced a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.
• In August 2026, the company announced a USPTO notice of allowance for a key U.S. patent for enobosarm and semaglutide; when issued, U.S. patent protection will last until at least October 2044.
• The allowed patent claims cover treatment regimens where enobosarm is given concurrently with semaglutide, added to initial semaglutide monotherapy, or continued as monotherapy after semaglutide discontinuation.
• The patent portfolio includes claims directed to preservation of lean body mass, muscle mass, enhancement of fat mass loss, improvement of physical function, preservation of bone, overcoming insulin resistance, improving HbA1c, and preventing weight/fat mass rebound after discontinuing semaglutide.
• The company owns a worldwide portfolio of patent applications directed to methods of use of enobosarm in combination with weight loss drugs, including incretin-containing drugs.
• A pending patent application for a novel, oral, modified-release enobosarm formulation, if issued, would provide patent protection until at least May 2046.
• The company received a gain on sale of ENTADFI® assets of $484,615 in the quarter ended June 30, 2025, and $2,154,134 in the nine months ended June 30, 2025.
• The company recorded a gain on extinguishment of debt of $8,624,778 in the nine months ended June 30, 2025.